MATERIAL SAFETY DATA SHEET

Transcription

1 Page 1 of 7 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York Emergency telephone number: CHEMTREC (24 hours): Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom (0) Emergency telephone number: ChemSafe (24 hours): +44 (0) Trade Name: Chemical Family: Intended Use: Demetrin; Centrac; Centrax; Reapam Mixture Pharmaceutical product used as Antidepressant/antianxiety. 2. COMPOSITION/INFORMATION ON INGREDIENTS Hazardous Ingredient CAS Number EU EINECS List % Maize starch * * Colloidal silicon dioxide * Magnesium stearate * Ingredient CAS Number EU EINECS List % Lactose * Additional Information: * Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. 3. HAZARDS IDENTIFICATION Appearance: Signal Word: Pale blue or white tablets. WARNING Statement of Hazard: Suspected of damaging fertility. May cause central nervous system effects Additional Hazard Information: Short Term: Not acutely toxic. Not expected to cause skin irritation ; eye irritation (based on components). Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on liver, male reproductive system. Known Clinical Effects: Therapeutic use of this substance has resulted in weakness, dizziness, drowsiness, ataxia, confusion, tremors, headache, and gastrointestinal disturbances. This material has been shown to be secreted in low concentrations in human breast milk. The following effects are based on a chemically-related material: symptoms of dependence/withdrawal, insomnia, amnesia, agitation, nightmares, hallucinations.

2 Page 2 of 7 EU Indication of danger: Toxic to Reproduction; Category 3 EU Hazard Symbols: EU Risk Phrases: Note: R62 - Possible risk of impaired fertility. This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace. 4. FIRST AID MEASURES Eye Contact: Skin Contact: Ingestion: Inhalation: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention immediately. Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention. Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately. Remove to fresh air and keep patient at rest. Seek medical attention immediately. 5. FIRE FIGHTING MEASURES Extinguishing Media: Hazardous Combustion Products: Fire Fighting Procedures: Fire / Explosion Hazards: Use carbon dioxide, dry chemical, or water spray. May emit toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride and other chlorine-containing compounds. During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus. Not determined 6. ACCIDENTAL RELEASE MEASURES Health and Safety Precautions: Measures for Cleaning / Collecting: Measures for Environmental Protections: Additional Consideration for Large Spills: Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure. Contain the source of spill if it is safe to do so. Collect spilled material by a method that controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of dry solids. Clean spill area thoroughly. Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release. Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel.

3 Page 3 of 7 7. HANDLING AND STORAGE General Handling: Storage Conditions: If tablets or capsules are crushed and/or broken, avoid breathing dust and avoid contact with eyes. Avoid generating airborne dust. Store at controlled room temperature. Protect from light. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Maize starch OSHA - Final PELS - TWAs: = 15 mg/m 3 TWA total = 5 mg/m 3 TWA ACGIH Threshold Limit Value (TWA) OSHA - Final PELS - TWAs: = 15 mg/m 3 TWA total = 5 mg/m 3 TWA ACGIH Threshold Limit Value (TWA) Colloidal silicon dioxide OSHA - Final PELs - Table Z-3 Mineral D: (80)/(% SiO2) mg/m 3 TWA = 20 mppcf TWA = 2 mg/m 3 TWA Magnesium stearate ACGIH Threshold Limit Value (TWA) except stearates of toxic metals Pfizer OEL TWA-8 Hr: 0.02 mg/m³ The exposure limit(s) listed for solid components are only relevant if dust may be generated. Analytical Method: Engineering Controls: Analytical method available for. Contact Pfizer Inc for further information. Engineering controls should be used as the primary means to control exposures. Personal Protective Equipment: Hands: Eyes: Skin: Respiratory protection: Not required for the normal use of this product. Wear protective gloves when working with large quantities. Not required under normal conditions of use. Wear safety glasses or goggles if eye contact is possible. Not required for the normal use of this product. Wear protective clothing when working with large quantities. If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL. 9. PHYSICAL AND CHEMICAL PROPERTIES: Physical State: Tablet Color: Pale blue or white Molecular Formula: Mixture Molecular Weight: Mixture

4 Page 4 of STABILITY AND REACTIVITY Stability: Conditions to Avoid: Incompatible Materials: Stable under normal conditions of use. Light No data available 11. TOXICOLOGICAL INFORMATION General Information: The information included in this section describes the potential hazards of the individual ingredients. Acute Toxicity: (Species, Route, End Point, Dose) Rat Oral LD50 > 5000 mg/kg Rabbit Dermal LD50 > 2000 mg/kg Lactose Rat Oral LD50 > 10 g/kg Mouse Oral LD g/kg Rat Oral LD50 >4 g/kg Rat IP LD50 >2 g/kg Mouse IP LD50 1 g/kg Magnesium stearate Rat Oral LD50 > 2000 mg/kg Rat Inhalation LC50 > 2000 mg/m 3 Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable at the highest dose used in the test. Irritation / Sensitization: (Study Type, Species, Severity) Skin Irritation Rabbit Non-irritating Eye Irritation Rabbit Non-irritating Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) 35 Day(s) Rat Oral 35 mg/kg LOAEL Liver, Male reproductive system 12 Week(s) Dog No route specified 13.5 mg/kg/day NOAEL Liver Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s)) Reproductive & Fertility Mouse Oral 0.02 % LOAEL Reproductive toxicity, Fetotoxicity Reproductive & Fertility Rat No route specified 80 mg/kg LOAEL Reproductive toxicity, Fetotoxicity Embryo / Fetal Development Rat Oral 250 mg/kg NOAEL Negative Embryo / Fetal Development Rabbit No route specified 80 times human dose NOAEL No effects at maximum dose Genetic Toxicity: (Study Type, Cell Type/Organism, Result) Genetic Toxicity Comments: Genetic toxicity tests were negative.

5 Page 5 of 7 Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s)) 2 Year(s) Rat Oral, in feed Not carcinogenic 2 Year(s) Mouse Oral, in feed Not carcinogenic Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. See below IARC: Group 3 Colloidal silicon dioxide IARC: Group ECOLOGICAL INFORMATION Environmental Overview: Environmental properties have not been thoroughly investigated. Releases to the environment should be avoided. 13. DISPOSAL CONSIDERATIONS Disposal Procedures: Dispose of waste in accordance with all applicable laws and regulations. 14. TRANSPORT INFORMATION Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. 15. REGULATORY INFORMATION EU Symbol: Xn EU Indication of danger: Toxic to Reproduction; Category 3 EU Risk Phrases: EU Safety Phrases: R62 - Possible risk of impaired fertility. S36/37 - Wear suitable protective clothing and gloves. S53 - Avoid exposure - obtain special instructions before use. OSHA Label:

6 Page 6 of 7 WARNING Suspected of damaging fertility. May cause central nervous system effects Canada - WHMIS: Classifications WHMIS hazard class: D2a very toxic materials Lactose EU EINECS List Maize starch EU EINECS List XU XU EU EINECS List Colloidal silicon dioxide EU EINECS List Magnesium stearate EU EINECS List Drug Enforcement Administration: Schedule IV Standard for the Uniform Scheduling Schedule 4 for Drugs and Poisons: EU EINECS List Additional Information: US DEA Schedule IV substance 16. OTHER INFORMATION Reasons for Revision: Updated Section 2 - Composition / Information on Ingredients. Updated Section 3 - Hazard Identification. Updated Section 8 - Exposure Controls / Personal Protection. Prepared by: Toxicology and Hazard Communication Pfizer Global Environment, Health, and Safety

7 Page 7 of 7 Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. End of Safety Data Sheet